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Extension Study of PRX-102 for 24 Months

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ClinicalTrials.gov Identifier: NCT01981720
Recruitment Status : Unknown
Verified January 2016 by Protalix.
Recruitment status was:  Enrolling by invitation
First Posted : November 11, 2013
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02. Patients will be enrolled to receive the same dose of PRX-102 (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg), as an intravenous infusion every 2 weeks for 24 Months.

Condition or disease Intervention/treatment Phase
Fabry Disease Drug: PRX-102 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for 24 Months to Adult Fabry Patients
Study Start Date : December 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1.0 mg/kg
PRX-102 1.0 mg/kg IV every 2 weeks
Drug: PRX-102
Other Name: chemically modified human alpha galactosidase
Experimental: 2.0 mg/kg
PRX-102 2.0 mg/kg IV every 2 weeks
Drug: PRX-102
Other Name: chemically modified human alpha galactosidase
Experimental: 0.2 mg/kg
PRX-102 0.2 mg/kg IV every 2 weeks
Drug: PRX-102
Other Name: chemically modified human alpha galactosidase


Outcome Measures

Primary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Every two weeks for 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of study PB-102-F02
  • The patient signs informed consent
  • Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method. Acceptable methods of contraception include hormonal products, intrauterine device, or male or female condoms. Contraception should be used for 1 month after treatment termination.

Exclusion Criteria:

  • Pregnant or nursing
  • Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981720


Locations
United States, Texas
Research Baylor Institute of Metabolic Disease
Dallas, Texas, United States, 75226
Paraguay
Instituto Privado de Hematologia E Investigacion Clinica (I.P.H.I.C)
Barrio Sajonia Asunción, Paraguay
Sponsors and Collaborators
Protalix
Investigators
Study Chair: Einat Almon, PhD Protalix Ltd
More Information

Responsible Party: Protalix
ClinicalTrials.gov Identifier: NCT01981720     History of Changes
Other Study ID Numbers: PB-102-F03
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Fabry Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders